Mycophenolate Mofetil and Placebo Show Similar Efficacy
Trial halted, no confirmed effect of mycophenolate mofetil on interstitial cystitis
MONDAY, Feb. 28 (HealthDay News) -- Mycophenolate mofetil (MMF) and placebo showed similar efficacy in treating symptoms of refractory interstitial cystitis/painful bladder syndrome (IC/PBS) before the premature termination of the trial, according to a study published in the March issue of The Journal of Urology.
Claire C. Yang, M.D., from the University of Washington in Seattle, and colleagues evaluated the efficacy and tolerability of MMF in 210 patients with IC/PBS. Participants of this 12-week multicenter, randomized, placebo-controlled trial had moderately severe symptoms and had at least three IC/PBS-specific treatment failures. Global response assessment was the primary end point of the study. General and disease-specific symptom questionnaires and voiding diaries were the secondary end points of the study. Fifty-eight participants (39 subjects and 19 controls) were assigned to either MMF or a placebo before a black box warning was issued by the manufacturer in October 2007. The trial was stopped, and results from the interim analysis were submitted to an independent data and safety monitoring board.
The investigators found that, at study termination, six subjects (15 percent) responded to MMF, compared to three controls (16 percent). Results of secondary outcome measures showed better improvement in controls.
"In a multicenter, randomized, placebo-controlled trial that was prematurely halted, MMF showed efficacy similar to that of placebo to treat refractory IC/PBS symptoms. The results of this limited study cannot be used to confirm or refute the hypothesis that immunosuppressive therapy may be beneficial to at least a subgroup of patients with IC/PBS," the authors write.
Several authors disclosed financial relationships with pharmaceutical companies.